Comparison the safety and efficacy of Adipose derived Stromal Cells -Seeded acellular dermal matrix and Adipose derived Stromal Cells injections in patients with diabetic foot ulcer resistant to standard care: Randomized clinical trial phase I/II

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适应症

试验速览

暂无简介。

•Age 18 -60
•Type 1 or Type 2 diabetes
•Able and willing to provide consent and agrees to comply with study procedures and follow-up evaluations
•Ulcer size 2-20 cm2
•Ulcer duration of more than 4 weeks, unresponsive to standard wound care
•No clinical signs of infection
•Serum creatinine <3 mg/dl
•HbA1c <12%
•ABI between 0·7 and 1·2

•wound duration of >52 weeks without intermittent healing
•Index ulcer probing to tendon, muscle, capsule or bone
•Currently receiving radiation or chemotherapy
•Known or suspected malignancy of current ulcer
•Diagnosis of autoimmune connective tissue disease
•Use of biomedical/topical growth factor within previous 30 days
•Pregnant or breast feeding
•Taking medications considered to be immune system modulators
•Allergy or known sensitivity to Gentamicin, Streptomycin or bovine collagen
•Wounds improving more than 20% over the 4-week run-in period of the trial using standard of care.
•Patient taking Cox-2 inhibitors.
•HBV, HCV or HIV positive.

发起方

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